Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer

NCT00060437 | Completed Phase 2

• 3 other identifiers: CDR0000301951NCI-03-C-0157NCI-5970
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer; adenocarcinoma of the prostate

Interventions

perifosine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria: * Metastatic * Androgen-independent * Progressive disease while continuing to receive hormonal ablation (e.g., luteinizing hormone-releasing hormone \[LHRH\] agonist) * Progression documented by at least 1 of the following parameters: * Two consecutively rising prostate-specific antigen levels, at least 1 week apart, with at least 1 measurement that is 50% above the nadir reached after the last treatment regimen (as long as the last measurement is at least 5 ng/mL) * At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy * Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following: * Development of new area of malignant disease (measurable or nonmeasurable) * At least a 20% increase in the sum of the longest diameters (LD) of target lesions from the smallest sum of LD recorded since the treatment started or the appearance of 1 or more new lesions * Patients who have not undergone surgical castration must have a testosterone level less than 50 ng/mL and continue on their LHRH agonist during study treatment * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No myocardial infarction within the past 6 months * No unstable or newly diagnosed angina pectoris * No New York Heart Association class II-IV congestive heart failure Ophthalmic * No pre-existing retinal disease * No pathologic baseline electrooculogram Other * Fertile patients must use effective barrier contraception * Able to ingest oral medication * No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine (e.g., miltefosine or edelfosine) * No ongoing or active infection * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No other active malignancies within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 1 prior chemotherapy regimen * More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) Endocrine therapy * See Disease Characteristics * More than 4 weeks since prior flutamide * More than 6 weeks since prior bicalutamide or nilutamide Radiotherapy * At least 6 weeks since prior bone-seeking radioisotopes * Recovered from prior radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery Other * Recovered from any acute toxicity related to prior therapy * More than 3 months since prior UCN-01 * More than 3 months since prior suramin * No concurrent commercial or other investigational agents or therapies intended to treat the malignancy * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (2)

• Posadas EM, Gulley J, Arlen PM, Trout A, Parnes HL, Wright J, Lee MJ, Chung EJ, Trepel JB, Sparreboom A, Chen C, Jones E, Steinberg SM, Daniels A, Figg WD, Dahut WL. A phase II study of perifosine in androgen independent prostate cancer. Cancer Biol Ther. 2005 Oct;4(10):1133-7. doi: 10.4161/cbt.4.10.2064. Epub 2005 Oct 1.

  PMID: 16138006 RESULT

• Posadas EM, Trout A, Senderowicz AM, et al.: A phase II trial of oral perifosine in patients with metastatic androgen-independent prostate cancer (AIPC). [Abstract] SUO/NCI Urologic Oncology Meeting, December 5-6, 2003, Bethesda, MD. A-54, 38, 2003.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

perifosine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Edwin M. Posadas, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: October 1, 2003
• Study Completion: April 1, 2004
• Last Updated: June 19, 2013

Record last verified: 2004-04

Locations

US (1)